Labelling medical device or a new in vitro diagnostic medical device for purpose of test, evaluation, clinical investigations, etc.Any medical device or new in vitro diagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 47 of 248 manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.CHAPTER VII CLINICAL INVESTIGATION OF MEDICAL DEVICE AND CLINICAL PERFORMANCE EVALUATION OF NEW IN VITRO DIAGNOSTIC MEDICAL DEVICE 49. Conduct of clinical investigation No person or sponsor shall conduct any clinical investigation in respect of investigational medical device in human participants except in accordance with these rules and in accordance with the permission granted by the Central Licensing Authority. 50. Application of rule 122DD of Drugs and Cosmetics Rules, 1945 with regard to Ethics Committee (1) The Ethics Committee constituted under rule 122DD of the Drugs and Cosmetics Rules, 1945 shall perform the functions and duties under these rules and shall be deemed to be constituted under these rules. (2) The provisions of Ethics Committee provided in rule 122DD of the Drugs Rules, 1945 shall, except where specifically provided under these rules, be applicable mutatis mutandis, for the purpose of clinical investigation and clinical performance evaluation under this Chapter.